FDA.reportPublic FDA data

Allergy Relief

Manufacturer
Harmon Store Inc. | LNK International, Inc.
Effective date
2023-05-09
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 21:31:34

Label at a glance#

ProductAllergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing 

Dosage and administration

do not take more than directed take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use

Storage and handling

each tablet contains: calcium 30 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from moisture see end flap for expiration date and lot number 

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg 

Purpose

OTC - PURPOSE SECTION

Antihistamine 

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing 

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin 

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers. 

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children 

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. 

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. 

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and over1 to 2 tablets
children 6 to under 12 years
1 tablet
children under 6 years
do not use

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 30 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from moisture
  • see end flap for expiration date and lot number 

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon
dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CORE VALUES™

Compare to active ingredient in
Benadryl® Allergy ULTRATAB®†

Allergy Relief

Diphenhydramine HCl 25 mg 
Antihistamine

Relieves:
• Sneezing
• Itchy Throat
• Runny Nose
• Itchy, Watery Eyes

Actual Size

24 coated mini-tabs

†This product is not manufactured or distributed
by Johnson & Johnson Corporation, owner of the
registered trademark Benadryl® Allergy ULTRATAB®.

50844       REV0721B32908

Distributed by: Liberty Procurement Co. Inc.,
650 Liberty Ave., Union NJ 07083 U.S.A.
Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Core Values 44-329 REV0721B
Core Values 44-329 REV0721B

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63940-32963940-329-12, 63940-329-08, 63940-329-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
STARCH, CORNO8232NY3SJIACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2b5309b8-2849-4893-aa6d-95f8a116643d61a00a2c-118e-4e19-9166-4a07663624822023-05-09WarningsExact identifier
spl id: 2b5309b8-2849-4893-aa6d-95f8a116643d
spl set id: 61a00a2c-118e-4e19-9166-4a0766362482

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.